CEN - EN ISO 11073-10419
Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin pump
|Publication Date:||1 June 2016|
|ICS Code (IT applications in health care technology):||35.240.80|
The scope of this standard is to establish a normative definition of communication between personal telehealth insulin pump devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core functionality of personal telehealth insulin pump devices.
In the context of personal health devices, an insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion (CSII) therapy.
This standard provides the data modeling according to the ISO/IEEE 11073-20601 standard, and does not specify the measurement method.
This standard addresses the need for an openly defined, independent standard that support information exchange to and from personal health devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes). Interoperability is key to growing the potential market for these devices and enabling people to be better informed participants in the management of their heath.